3种熊果苷的安全性评价进展及其化妆品法规管理现状

doi:10.3969/j.issn.2097-2806.2024.07.013

Abstract

Abstract:

α-arbutin, β-arbutin and deoxyarbutin have good whitening effect, but they are easy to produce hydroquinone under certain conditions, which has the risk of exogenous ochronosis, achromodermia, sensitization, and carcinogenesis. So their safety has attracted much attention at home and abroad. The author summarizes the safety evaluation reports of α-arbutin, β-arbutin and deoxyarbutin by the Scientific Committee on Consumer Safety （SCCS） of the European Union in recent years, as well as the supervision situation of cosmetics regulations in different countries and regions, in order to understand the safety evaluation status of arbutin and provide references for the use and supervision of arbutin in cosmetics in China.

Key words: arbutin, safety evaluation, skin whitening, cosmetics regulations

CLC Number:

TQ658

Jiaojiao Wu, Wei Zhang, Yanchao Wang, Xinrong Pei. Safety evaluation progress of three kinds of arbutin and its current status in cosmetics regulations[J].China Surfactant Detergent & Cosmetics, 2024, 54(7): 853-858.

Figures/Tables 1

References 29

[1]	Zhang Fenglan, Wu Jing, Wang Gangli, et al. Investigation on the using of whitening ingredients in skin whitening cosmetics[J]. Chinese Journal of Health Laboratory Technology, 2017, 27 (20) : 3012-3015.
[2]	Fang Jun, Du Shunjing, Jin Yinlong. Research progress on the application of arbutin in cosmetics[J]. Journal of Hygiene Research, 2009, 38 (1) : 111-113.
[3]	Rudeekulthamrong Prakam, Kaulpiboon Jarunee. Optimization of amylomaltase for the synthesis of α-arbutin derivatives as tyrosinase inhibitors[J]. Carbohydrate Research, 2020, 494: 108078-108085.
[4]	Zhu Wenyuan, Gao Jie. The use of botanical extracts as topical skin-lightening agents for the improvement of skin pigmentation disorders[J]. The Journal of Investigative Dermatology Symposium Proceedings, 2008, 13 (1) : 20-24.
[5]	Yan Xiufang, Zhang Xin, Fan Qianwen. Study on stability of β-arbutin as a cosmetic whitening ingredient[J]. China Surfactant Detergent & Cosmetics, 2019, 49 (3) : 178-182.
[6]	Yong Chool Boo. Arbutin as a skin depigmenting agent with antimelanogenic and antioxidant properties[J]. Antioxidants, 2021, 10 (7) : 1129-1150.
[7]	Khalilpour Asieh, Pouramir Mahdi, Asgharpour Fariba. Evaluation of antioxidant stability of arbutin and Pyrus boissieriana Buhse leaf extract[J]. International Journal of Molecular and Cellular Medicine, 2013, 2 (2) : 86-92. pmid: 24551796
[8]	Zhang Fenglan, Wu Jing, Wang Gangli, et al. Whitening effect of α-arbutin and deoxyarbutin and safety evaluation: a review of recent studies[J]. Journal of Environment and Health, 2018, 35 (4) : 370-375.
[9]	Scientific Committee on Cosmetic Products and Non-Food Products. Products and non-food products intended for consumers concerning hydroquinone as a skin depigmentating agent: SCCNFP/0077/98[EB/OL]. (1998-11-25)[2023-07-15]. https://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/sccnfp_opinions_97_04/sccp_out46_en.htm.
[10]	Cosmetic Ingredient Review. Amended safety assessment of hydroquinone as used in cosmetics[EB/OL]. (2015-01-13)[2023-07-15]. https://cir-reports.cir-safety.org/view-attachment/?id=25e8bd9b-8c74-ec11-8943-002.2482f06a6.
[11]	Japan Ministry of Health, Labour and Welfare. Pharmaceutical and Food Safety Bureau and Ministry of Health and Welfare. Standards for cosmetics: Notification No.331 of 2010[EB/OL]. (2000-09-29)[2023-07-15]. https://www.mhlw.go.jp/web/t_doc?dataId=81aa1263&dataType=0&pageNo=1.
[12]	China Food and Drug Administration. Safety and Technical Standards for Cosmetics[M]. Beijing: People’s Health Publishing House, 2015: 7.
[13]	Zhang Fenglan, Su Zhe, Wu Jing, et al. Safety evaluation of β-arbutin and hydroquinone and current status of cosmetics regulation[J]. Journal of Environment and Health, 2017, 34 (11) : 1017-1021.
[14]	Scientific Committee on Consumer Safety. Opinion on β-arbutin: SCCP/1158/08[EB/OL]. (2008-04-15)[2023-07-15]. https://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_134.pdf.
[15]	Scientific Committee on Consumer Safety. Opinion on β-arbutin: SCCS/1550/15[EB/OL]. (2015-03-25)[2023-07-15]. https://health.ec.europa.eu/document/download/98964c4a-adad-4809-ab06-e96c01ffddff_en?filename=sccs_o_169.pdf.
[16]	Scientific Committee on Consumer Safety. Opinion on α-arbutin: SCCS/1552/15[EB/OL]. (2015-05-27)[2023-07-15]. https://health.ec.europa.eu/document/download/eff67158-e3f6-4aef-9594-4e1b5789bb67_en?filename=sccs_o_176.pdf.
[17]	Scientific Committee on Consumer Safety. Opinion on the safety of alpha-arbutin and beta-arbutin in cosmetic products: SCCS/1642/22[EB/OL]. (2023-01-31)[2023-07-15]. https://health.ec.europa.eu/document/download/66cdc38f-68e7-4e47-b06a-7ba73b027fb6_en?filename=sccs_o_264.pdf.
[18]	Scientific Committee on Consumer Safety. Opinion on deoxyarbutin tetrahydropyranyloxy phenol: SCCS/1554/15[EB/OL]. (2015-06-25)[2023-07-15]. https://health.ec.europa.eu/document/download/255e0959-70fb-45ba-a918-88005d73f17c_en?filename=sccs_o_183.pdf.
[19]	National Medical Products Administration. Announcement of the National Medical Products Administration on the release of the Catalogue of Used Cosmetic ingredients (2021 Edition) (No. 62 of 2021)[EB/OL]. (2021-05-12)[2023-07-15]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210430162707173.html.
[20]	General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, National Standardization Commission. Announcement on approval and release of 291 national standards such as Technical Requirements for Solid Wood Flooring for Ground Heating, 3 amendments to national standards and 60 foreign versions of national standards[EB/OL]. (2018-02-06)[2023-07-15]. https://std.sacinfo.org.cn/gnoc/queryInfo?id=153BDDECD555A1A284326BAB2F3F0771.
[21]	National Institutes for Food and Drug Control. Notice of the NIFDC on soliciting opinions on the revision of the “Safety and Technical Standards for Cosmetics”[EB/OL]. (2022-03-31)[2023-07-15]. https://www.nifdc.org.cn/nifdc/bshff/hzhpbzh/hzhpbzhtzgg/2022033116124546136.html.
[22]	European Commission. Commission Regulation (EU) 2021/1099 of 5 July 2021 amending Annexes Ⅱ and Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)[EB/OL]. (2021-07-06) [2023-07-15]. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32021R1099.
[23]	European Commission. Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-arbutin and arbutin and certain substances with potential endocrine disrupting properties in cosmetic products[EB/OL]. (2023-06-08)[2023-07-15]. https://ec.europa.eu/growth/tools-databases/tbt/en/search/?tbtaction=search.detail&Country_ID=EU&num=986&dspLang=en&basdatedeb=&basdatefin=&baspays=&basnotifnum=986&basnotifnum2=&baskeywords=&bastypepays=&baskeywords=.
[24]	Ando Hideya, Matsui Mary S, Ichihashi Masamitsu. Quasi-drugs developed in Japan for the prevention or treatment of hyperpigmentary disorders[J]. International Journal of Molecular Sciences, 2010, 11 (7) : 2699-2700.
[25]	Korea Ministry of Food and Drug Safety. Relevant regulations on functional cosmetics examination[EB/OL]. (2019-06-17)[2023-07-15]. https://www.mfds.go.kr/brd/m_211/view.do?seq=14333.
[26]	Committee on technical barriers to trade. The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022[EB/OL]. (2022-04-13)[2023-07-15]. https://members.wto.org/crnattachments/2022/TBT/GBR/22_2823_00_e.pdf.
[27]	Huang Xianglu, Liu Min, Xing Shuixia, et al. Mandatory regulations and standards regarding skin bleaching/whitening products in major countries and regions[J]. Flavour Fragrance Cosmetics, 2020 (6) : 91-97.
[28]	The Food and Drug Administration of Taiwan’s Ministry of Health and Welfare. What whitening ingredients can be used in cosmetics as announced by the Ministry of Health and Welfare?Do I need to apply for the pre-market inspection registration manual?[EB/OL]. (2008-12-01)[2023-07-15]. https://www.fda.gov.tw/tc/faqContent.aspx?pn=25&id=247.
[29]	National Medical Products Administration. Announcement of the State Food and Drug Administration on the release of the Technical Guidelines for Cosmetic Safety Assessment (2021 version) (No. 51 of 2021)[EB/OL]. (2021-04-08)[2023-07-15]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210419163037171.html.

Safety evaluation progress of three kinds of arbutin and its current status in cosmetics regulations

RichHTML

PDF (PC)

Like

Knowledge

Abstract

Cite this article

share this article

Figures/Tables 1

References 29

Related Articles 15

Metrics

Comments

Recommended 10

[1]	He Miao, Su Zhe, Hu Kang, Zhang Fenglan, Wang Gangli, Lu Yong. Discussion of cosmetic ingredient management and regulatory system of cosmetic ingredient safety information submission [J]. China Surfactant Detergent & Cosmetics, 2023, 53(9): 1080-1086.
[2]	Yan Jun,Wang Rong,Li Zehua,Zhang Liyuan,Cheng Qiaoyuan,Yan Linqi. Simultaneous determination and usage analysis of six functional ingredients in whitening cosmetics [J]. China Surfactant Detergent & Cosmetics, 2022, 52(7): 791-796.
[3]	Wang Dongdong,Sun Qianru,Wang Ziwen,Fang Jiaxuan,Li Meng,Wang Changtao. Study on the anti-aging and whitening effects of grape seed fermentation broth [J]. China Surfactant Detergent & Cosmetics, 2022, 52(5): 545-552.
[4]	Li Ziyi,Liu Yan,Zhang Zhao,Wu Huiqin. Preparation of a papain-embedding biological membrane material and its application in the skin-whitening products [J]. China Surfactant Detergent & Cosmetics, 2022, 52(3): 294-301.
[5]	Su Zhe,Hu Kang,Wang Gangli,Lu Yong. Establishment and prospects of the database for safety information on cosmetic ingredients in China [J]. China Surfactant Detergent & Cosmetics, 2022, 52(11): 1221-1228.
[6]	Ren Qianqian,Wu Hua,Jin Jianming. Botanical cosmetic ingredient (IV) Research and development of skin whitening ingredients from plant extracts with melanogenesis signaling pathway inhibiting effect [J]. China Surfactant Detergent & Cosmetics, 2021, 51(7): 590-597.
[7]	REN Qian-qian,WU Hua,JIN Jian-ming. Botanical cosmetic ingredient （Ⅱ）Research and development of tyrosinase inhibitors from plant extracts in skin whitening [J]. China Surfactant Detergent & Cosmetics, 2021, 51(3): 178-185.
[8]	LIU Juan,YANG Li,PANG Jian-ping,ZHENG Hong-yan,JIA Xue-ting,SU Ning. Research on skin penetration of β-arbutin by confocal Raman spectroscopy [J]. China Surfactant Detergent & Cosmetics, 2019, 49(7): 452-455.
[9]	LIU Fang,ZHANG Qian,YANG Bin,HE Hua-kang,YANG Lei,GUO Chun-hua. Study on preparation process and safety evaluation of handmade soap containing Corni Fructus polysaccharide [J]. China Surfactant Detergent & Cosmetics, 2019, 49(4): 248-252.
[10]	LI Wu-yun-ta-na,ZHAO Jun-cai,WANG Ping,DING Xiao-jing. Simultaneous determination of phenol, hydroquinone, arbutin, andkojic acid in whitening cosmetics by micellar electrokinetic capillary chromatography [J]. China Surfactant Detergent & Cosmetics, 2019, 49(4): 275-278.
[11]	Xiu-fang YAN,Xin ZHANG,Qian-wen FAN. Study on stability of β-arbutin as a cosmetic whitening ingredient [J]. China Surfactant Detergent & Cosmetics, 2019, 49(3): 178-182.
[12]	ZHAO Hua, WANG Nan. Efficacy evaluation of cosmetics (Ⅲ) Scientific supports for whitening cosmetic efficacy claims [J]. China Surfactant Detergent & Cosmetics, 2018, 48(3): 129-133.
[13]	JIANG Zhen-juan, CHEN Zhi-tao. Influence of β-arbutin on analysis result of hydroquinone in cosmetics by GC-MS [J]. China Surfactant Detergent & Cosmetics, 2017, 47(2): 118-120.
[14]	YIN Yue-xuan, QIU Xiao-feng, YANG Cui-lan, LI Cheng-tong, ZHAO Hua. Evaluating the effect of mask material on its performance based on subjective and objective analysis methods [J]. China Surfactant Detergent & Cosmetics, 2017, 47(12): 703-708.
[15]	CAI Rui, HE Wen-dan, TANG Ying, PAN Yao, ZHAO Hua. Progress with respect to safety evaluation methods for cosmetic photoirritation and photoallergy [J]. China Surfactant Detergent & Cosmetics, 2017, 47(10): 588-592.